Since the last publication of our Dynamic Top Pick List on 5 June 2025, our selection has seen again a nice outperformance versus the reverence indices (AEX, Bel20 and Eurostoxx50) of on average 3.3%. Our July update brings 3 adjustments to the list : Since being added to the list in December 2024, Fagron's share price has surged +/-22%, driven by strong Q1 2025 results and robust growth across all regions. Fagron reaffirmed its FY25 guidance and unveiled its “Compounding for Growth” strategy, ...
Euronext statement regarding recent press speculations Euronext statement regarding recent press speculations Amsterdam, Brussels, Dublin, Lisbon, Milan, Oslo and Paris – 1 July 2025 – Euronext notes recent speculations. Euronext confirms that it has entered into discussions with the board of directors of HELLENIC EXCHANGES-ATHENS STOCK EXCHANGE S.A. (“ATHEX”), the Greek capital markets operator, about a possible offer to acquire up to 100% of the shares of ATHEX. This potential offer would be structured as a share exchange valuing ATHEX at €6.90 per share, leading to a fixed conversion ra...
Onward has submitted two key regulatory applications for its ARC-EX system, a non-invasive neurostimulation device designed to improve hand function after spinal cord injury. Following its US clinic-use approval in December 2024 and initial sales of ten units in Q1 2025, the company has now filed a 510(k) with the FDA to enable home use in the US and a CE mark application under MDR for commercialization in the EU. Onward expects both approvals by YE25. The company remains confident in meeting it...
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord ...
MaaT provides a business update, which reiterated the company's progress with respect to its pipeline, and following the previously announced EU regulatory submission for MaaT013 in aGvHD, the company continues to search for a commercialisation partner in Europe ahead of a potential approval in 2H26. Timeline for MaaT013 US trial launch shifts to 2026 (from 4Q25) to focus resources on the European opportunity. Looking ahead, data updates for MaaT013 in aGvHD (final results incl. 12-month OS), as...
A director at Euronext N.V. sold 2,543 shares at 142.000EUR and the significance rating of the trade was 68/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly s...
Onward's 1Q25 update highlights steady progress across commercial and clinical fronts. The company sold ten ARC-EX systems in its limited US launch, with positive feedback and a target of 30 units for 1H25. It reported € 0.4m revenue and held € 50.5m net cash at the end of the quarter, in line with our expectations. Upcoming regulatory milestones continue to be the anticipated FDA home use label expansion and CE mark approval, as well as IDE approval for the pivotal Empower BP study. €10.4 TP/Bu...
ONWARD Medical Builds Commercial Momentum for the ARC-EX System and Reinforces its Brain-Computer Interface Leadership in Q1 2025 EINDHOVEN, the Netherlands, June 17, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces its Q1 2025 business update and year-to-date highlights: Commercial traction: Following FDA market authorization, the Company met its Q1 objective for...
MaaT reported updated early access program (EAP) results for MaaT013 (microbiome therapy, enema formulation) in aGvHD at EHA, being held 12-15 June. The data, which was previously shared in the abstract last month, shows that the response rates and overall survival observed in the steroid refractory and ruxulitinib resistant subset of patients (n=70) are in line with what was observed in the phase 3 ARES trial. In our view, this points to the consistency of outcomes with MaaT013 in this patient ...
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